| Domain | Ethical requirements[19] | Ethical principles[18] | Sample reasons for not participating in a clinical trial[15, 22, 41, 52] |
---|---|---|---|---|
Patient-trial fit | ||||
Institution | 5-Independent review | Beneficence | Cannot identify patients | |
Patients seek services elsewhere | ||||
2-Scientific validity | Cannot enroll enough patients | |||
Unavailability | ||||
No measureable/confirmable disease | ||||
1-Social value | Justice | No testable treatments for the disease, stage, or other characteristics | ||
Investigators | ||||
Eligibility [9] | 3-Fair subject selection justice | Prior tumor, second cancer, metastases | ||
Precluded by prior or current treatment or co-morbid conditions | ||||
Beneficence | Poor performance status | |||
Asymptomatic | ||||
Study demands | ||||
Physician triage [25] | Physician | 4-Favorable risk-benefit ratio | Treatment not tolerated, died soon, disease is too advanced | |
Quality of life issues | ||||
Life expectancy is limited | ||||
Need for immediate treatment | ||||
Physician preference/judgment | ||||
Opportunity | ||||
Physician | 6-Informed and voluntary consent | Respect for persons | Physician judged compliance issues | |
Doctor-patient communication issues | ||||
Patient | 6-Informed and voluntary consent | Respect for persons | Treatment preference /placebo | |
Minimal care: symptomatic treatment only, supportive or hospice care desired, refused further staging | ||||
Not interested | ||||
Barriers: distant from clinic [5], financial, insurance [48], personal circumstances | ||||
Second opinion only, return to home physician, no ongoing relationship | ||||
Acceptance | ||||
Patient consent [45] | Patient | 6-Informed and voluntary consent | Respect for persons | Fear of randomization |
Fear of side effects | ||||
Negative aspects of a trial participation, distance | ||||
Patient enrollment | Investigator | 7-Respect for enrolled subjects | Patient failed trial screening protocol | |
 |  |  |  | Withdrawal |